Safety and Accuracy of Robot-assisted Versus Fluoroscopy-assisted Screw Insertion in Spinal Surgery: a Prospective Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Deviation of guide pin placement position
研究概览
简要总结
The investigators present the design of a randomized trial to compare the accuracy and safety of screw insertion using the robot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter. The accuracy and safety of screw insertion are measured by deviation of guide pin placement position, deviation of screw placement position, and intraoperative or postoperative complications. Secondary outcome parameters such as radiation exposure, postoperative recovery, duration of surgery, length of hospital stay and economic appraisal were also evaluated and compared between treatment groups.
详细描述
In spinal surgery, the accurate placement of implants is the key to ensure the success of the surgery, to achieve the safety and clinical requirements of internal fixation. Robot-assisted technology has become an effective means to improve the accuracy of implants with higher accuracy, free from fatigue and equivalent repetitive operation. The investigators present the design of a randomized trial to compare the accuracy and safety of screw insertion using the robot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter.
500 participants per group (1000 participants in total) are being recruited after diagnosis and before treatment through multi-hospital system and randomised to 1) robot-assisted technique or 2) conventional fluoroscopy-assisted technique in spine surgery. Outcomes are being measured pre-operatively, during- surgery and at 3, 6, 12 months post-surgery. The accuracy and safety of screw insertion are measured by deviation of guide pin placement position, deviation of screw placement position, and intraoperative or postoperative complications. Secondary outcome parameters such as radiation exposure, postoperative recovery, duration of surgery, length of hospital stay and economic appraisal were also evaluated and compared between treatment groups.
The study is addressing key questions of importance by evaluating the TiRobot-assisted technique versus the conventional fluoroscopy-assisted technique in spine surgery at multicenter. Outputs include evidence to facilitate more effective and safe decision making about surgical treatment for spine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18 or above, gender not limited;
- •patients eligible for surgery;
- •the patient signed the informed consent and agreed to participate in this study.
排除标准
- •patients with severe osteoporosis;
- •patients with old fractures;
- •patients with developmental deformity of the vertebral body with screw placement;
- •patients complicated with severe systemic diseases;
- •patients with coagulation dysfunction;
- •patients deemed unsuitable for the test by the clinical institution.
研究组 & 干预措施
conventional fluoroscopy-assisted technique
干预措施: Freehand (Device)
robot-assisted technique
干预措施: the TiRobot system (Device)
结局指标
主要结局
Deviation of guide pin placement position
时间窗: during operation
After completing guide pin placement preparation, do the C arm scan, obtain 3-D scanning image, plan on the image, position by the robot, finish the needle placement and obtain 3-D scanning image again. Fusion two groups of the image, measure the distance between the entry and exit points of the guide pin and the surgical planning, calculate the insertion deviation, and evaluate the insertion accuracy of the guide pin. Insertion deviation = (Input offset distance + Output offset distance) / 2, the unit is mm. If more than one guide pin is needed for the operation, the deviation of the insertion shall be calculated separately and the average shall be taken.
Time of guide pin adjustion
时间窗: during operation
After the guide pin is placed, when the position deviation needs to be adjusted, the time consumed by adjusting the guide pin.
Intraoperative Complications
时间窗: After operation up to 4 weeks
Intraoperative complications, including but not limited to: positioning complications (blindness, nerve injury, skin breakdown), acute spinal cord injury, vascular Injury(vertebral injury, aorto-iliac injury), cardiovascular events, pulmonary complications, acute kidney injury.
Deviation of screw placement position
时间窗: during operation
Postoperative screw placement position deviation was measured. The position of spinal screws was evaluated by postoperative imaging. Standard for classification of spinal screw placement : Excellent：The screw was completely in the pedicle and did not penetrate the cortex. Good: The screw cortical perforation \< 2mm, or less than 50% of the screw diameter. Bad： The screw cortical perforation \> 2mm, or more than 50% of the screw diameter.
Time of screw adjustion
时间窗: during operation
After the screw is placed, when the position deviation needs to be adjusted, the time consumed by adjusting the screw.
Postoperative Complications
时间窗: The time was within 1 year after the operation.
Postoperative complications，including but not limited to: cardiovascular events, pulmonary complications, acute kidney injury, ileus, coagulopathy and wound infection. The time was within 1 year after the operation.
次要结局
- Duration of surgery(during operation)
- Radiation exposure(during operation)
- JOA score 24 hours before surgery(24 hours before surgery)
- Visual analogue scale (VAS) score 24 hours after surgery(24 hours after surgery)
- Visual analogue scale (VAS) score 24 hours before surgery(24 hours before surgery)
- Visual analogue scale (VAS) score 6 months after surgery(6 months after surgery)
- JOA score 6 months after surgery(6 months after surgery)
- NDI score 3 months after surgery(3 months after surgery)
- ODI score 24 hours before surgery(24 hours before surgery)
- Health related quality of life 3 months after surgery(3 months after surgery)
- JOA score 1 year after surgery(1 year after surgery)
- NDI score 24 hours before surgery(24 hours before surgery)
- NDI score 6 months after surgery(6 months after surgery)
- Economic appraisal(The time was within 1 year after the operation.)
- Visual analogue scale (VAS) score 3 months after surgery(3 months after surgery)
- Visual analogue scale (VAS) score 1 year after surgery(1 year after surgery)
- JOA score 24 hours after surgery(24 hours after surgery)
- JOA score 3 months after surgery(3 months after surgery)
- NDI score 24 hours after surgery(24 hours after surgery)
- Health related quality of life 1 year after surgery(1 year after surgery)
- NDI score 1 year after surgery(1 year after surgery)
- ODI score 24 hours after surgery(24 hours after surgery)
- Health related quality of life 6 months after surgery(6 months after surgery)
- length of hospital stay(Up to the 4 weeks)
研究者
Wei Tian
President of Beijing Jishuitan Hospital
Beijing Jishuitan Hospital